- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05543473
Effect of Vestibular Rehabilitation Therapy on Patients With Brain Radiological Findings That Affect Balance Functions
Occurrence of cerebrovascular diseases, particularly of cerebral small vessel disease (SVD), appears to play some role in the development of gait and balance impairment . Beside small vessel disease , stroke is one of the most common cause of long-term adult disability leading to cognitive and motor function impairments. Particularly, gait and balance disorders that may contribute to immobility and falls.
The design of personalized rehabilitation protocols, focused on the recovery of dynamic balance ability would be fundamental to reduce these deficits and consequently, the risk of falling, thus improving patients' quality of life. Vestibular rehabilitation therapy (VRT) is an exercise-based treatment program designed to promote vestibular adaptation and substitution. The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living. VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed A Abdelrahman, professor
Study Contact Backup
- Name: Marwa N Fahmy, residant
- Phone Number: 01018371517
- Email: marwanasser@med.sohag.edu.eg
Study Locations
-
-
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Sohag, Egypt
- Recruiting
- Sohag university Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: from 40 years to 60 years old.
- Sex: males and females.
- Can withstand and willing to undergo repeated CDP trials.
- No evidence of orthopedic problems, neurological or cardiovascular diseases. - No history of any disease required to give treatment that could affect results.
Exclusion Criteria:
- Geriatric population , above age 60 years old.
- Patients with orthopedic problems , neurological or cardiovascular diseases.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: patients
patients with brain radiological findings that affect balance functions
|
an exercise-based treatment program designed to promote vestibular adaptation and substitution.
The goals of VRT are to enhance gaze stability, to enhance postural stability, to improve vertigo, and to improve activities of daily living.
VRT facilitates vestibular recovery mechanisms: vestibular adaptation, substitution by the other eye-movement systems, substitution by vision, somatosensory cues, other postural strategies, and habituation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of change in balance function
Time Frame: 3 months after the end of Vestibular rehabilitation therapy
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The computerized dynamic posturography sensory organization test (CDP-SOT)
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3 months after the end of Vestibular rehabilitation therapy
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ahmad H, Cerchiai N, Mancuso M, Casani AP, Bronstein AM. Are white matter abnormalities associated with "unexplained dizziness"? J Neurol Sci. 2015 Nov 15;358(1-2):428-31. doi: 10.1016/j.jns.2015.09.006. Epub 2015 Sep 4.
- Alcock L, O'Brien TD, Vanicek N. Association between somatosensory, visual and vestibular contributions to postural control, reactive balance capacity and healthy ageing in older women. Health Care Women Int. 2018 Dec;39(12):1366-1380. doi: 10.1080/07399332.2018.1499106. Epub 2018 Nov 5.
- Alyono JC. Vertigo and Dizziness: Understanding and Managing Fall Risk. Otolaryngol Clin North Am. 2018 Aug;51(4):725-740. doi: 10.1016/j.otc.2018.03.003. Epub 2018 May 24.
- Ekvall Hansson E, Pessah-Rasmussen H, Bring A, Vahlberg B, Persson L. Vestibular rehabilitation for persons with stroke and concomitant dizziness-a pilot study. Pilot Feasibility Stud. 2020 Sep 30;6:146. doi: 10.1186/s40814-020-00690-2. eCollection 2020.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-22-07-13
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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